ClinicalTrials.gg
CompletedNCT07876011Updated Oct 15, 2026

Short-term Changes in Postural Sway, Gait, and fNIRS-derived Cortical Metrics After a 4-week AI-assisted Exercise Program: a Single-arm Pre-post Study

An interventional study of AI-assited exercise in Fall Risk in Middle-Aged and Older Adults, sponsored by Peking University Third Hospital. Completed at 1 site in China. Open to participants aged 52 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jan 2025, registered Oct 2026).
Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
52 Years to 70 Years
Sex
All
01

Study summary

This single-arm pre-post study will enroll 50 participants aged 52-65 years who will undergo a 4-week AI-assisted exercise intervention. Postural balance, functional near-infrared spectroscopy (fNIRS), and three-dimensional motion capture data will be assessed before and after the intervention under different task conditions. During the dual-task condition, the correct response rate (CRR) during serial subtraction of 7 will be recorded. Adverse events occurring during the intervention will also be monitored and recorded.

02

Conditions studied

  • Fall Risk in Middle-Aged and Older Adults
03

In context

Lead sponsor

Peking University Third Hospital is the lead sponsor of 749 studies on the registry; 270 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
52 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 52-70 years, regardless of sex.
  • Able to walk independently for at least 10 meters without any assistive device.
  • Normal or corrected-to-normal vision and normal hearing, with the ability to understand and complete all study procedures as instructed.
  • Willing to participate in the study and provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Severe musculoskeletal, neurological, cardiopulmonary, or psychiatric diseases or a history of such conditions.
  • Severe cognitive impairment.
  • A history of drug or substance abuse within the past 3 months.
  • Any other condition that may affect participation in or the assessment of the study.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    AI-Assisted Exercise

    Participants will receive a 4-week combined exercise intervention, 5 days per week with 2 days of rest. Each 60-minute session will include 10 minutes of warm-up, 20 minutes of AI-assisted lower-extremity strength and functional training, 20 minutes of aerobic cycling, and 10 minutes of cool-down. The AI-assisted training system will provide individualized exercise guidance, real-time monitoring, and movement correction. Aerobic cycling will be performed at approximately 55% heart rate reserve using a recumbent cycle ergometer. Safety and adverse events will be monitored throughout the intervention.

    Behavioral: AI-assited exercise

Interventions

  • BehavioralAI-assited exercise

    A 4-week AI-assisted combined exercise intervention consisting of lower-extremity strength and functional training and aerobic cycling, delivered 5 days per week with individualized guidance and real-time movement monitoring.

06

What researchers measure

Primary outcomes

  1. gait speed

    Time frame: Baseline and immediately after completion of the 4-week intervention

Secondary outcomes

  1. sway area

    Area of the 95% confidence ellipse of the acceleration signal in postural sway data

    Time frame: Baseline and immediately after completion of the 4-week intervention

  2. PFC_HbO

    Change in prefrontal cortex oxygenated hemoglobin concentration (fNIRS)

    Time frame: Baseline and immediately after completion of the 4-week intervention

  3. double support

    Mean percentage of the gait cycle spent in double-support phase across both lower limbs

    Time frame: Baseline and immediately after completion of the 4-week intervention

Other outcomes

  1. lateral variability

    Standard deviation of left and right step lengths

    Time frame: Baseline and immediately after completion of the 4-week intervention

  2. Global efficiency (fNIRS)

    Global efficiency (GE) is a graph-theoretical measure of the efficiency of information integration across the entire brain functional network. It is defined as the average of the inverse shortest path length between all pairs of network nodes, with higher GE indicating more efficient global information transfer across the network.

    Time frame: Baseline and immediately after completion of the 4-week intervention

07

Study locations

1 site
  • Peking University Third Hospital Chongli Hospital, Yingbin Road, Chongli District, Zhangjiakou, Hebei, China
    Zhangjiakou, Hebei, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2025 to primary completion in Oct 2025, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2026
First posted
Oct 15, 2026
StartActual
Jan 8, 2025
Primary completionActual
Oct 20, 2025
CompletionActual
Oct 20, 2025
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07876011
Responsible party
Liu Zhenlong (Associate Researcher, Associate Chief Physician, Peking University Third Hospital) — Principal investigator
First posted
Oct 15, 2026
Start date
Jan 8, 2025
Primary completion
Oct 20, 2025
Completion
Oct 20, 2025
Last update
Oct 15, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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